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When Was The Institutional Review Board Established?

When Was The Institutional Review Board Established
Administration – Today, four IRBs review biomedical and behavioral research involving human subjects at Fred Hutch. The IRBs review all research submitted by Fred Hutch and the Fred Hutch/University of Washington Cancer Consortium. The Fred Hutch IRBs review any research project involving research participants, regardless of its funding source.

Fred Hutch IRBs review and approve research in accordance with U.S. Department of Health and Human Services regulations at 45 CFR 46, In addition, for studies involving products regulated by the U.S. Food and Drug Administration, the Fred Hutch IRBs comply with the requirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312 and 21 CFR 812.

The chairs of each IRB are:

Committee A: Brenda Sandmaier, M.D. Committee B: David Maloney, M.D., Ph.D Committee C: Roland Walter, M.D., Ph.D., M.S. Committee D: Stacey Cohen, M.D.

The Institutional Review Office, or IRO, administers all activities requiring IRB review. The IRO reports directly to the Office of the Director of Fred Hutch. Fred Hutch IRB meetings are held four times per month. View the schedule of meetings and submission deadlines.

Who created Institutional Review Board?

Where Does an IRB Get Its Authority? – In 1974, the Department of Health Education and Welfare promulgated the regulations on the Protection of Human Subjects that established the IRB. IRBs are administered on a federal level by the Office for Human Research Protections (OHRP), an office within the Department of Health and Human Services.

Why was IRBs created?

The recognition of the need for guidelines dealing with human subjects in research emerged following the Nuremberg trials, where the medical experimentation abuses of World War II Nazi doctors came to public attention. This led to the creation of the Nuremberg Code in 1945, the first legal attempt to deal with ethical issues of modern research.

  • As biomedical research efforts expanded the international need for a more specific code of ethics was formulated in the 1964 Declaration of Helsinki.
  • In the United States, by 1953 the National Institutes of Health required that all proposed clinical research projects at its center in Bethesda obtain approval from a protection of human subjects review panel.

In 1966, the United States Public Health Service issued its first set of regulations extending this review requirement to all “extramural” research supported by the agency. These rules were further revised in 1971 and 1974 and led to the establishment of institutional review boards (IRBs) at hundreds of institutions receiving federal funding for research.

  • During this period revelations of human subjects’ abuse in the U.S.
  • Culminated in the 1972 public disclosure of the 30-year government supported Tuskegee Syphilis Study, in which 300 black rural men were left untreated for diagnosed syphilis after effective antibiotics became available.
  • This prompted Public Law 93-348 calling for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

In 1979 the Commission published recommendations, known as the Belmont Report, which served as the basis for revised federal regulations published in the Federal Register in 1979 and subsequently revised several times resulting in the current Code of Federal Regulations Title 45-Part 46 Protection of Human Subjects (45 CFR 46) effective as of 1991.

Beneficence: To maximize benefits for science, humanity, and research participants and to avoid or minimize risk or harm. Respect: To protect the autonomy and privacy rights of participants. Justice: To ensure the fair distribution among persons and groups of the costs and benefits of research.

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What is an an institutional review board?

Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

  1. This group review serves an important role in the protection of the rights and welfare of human research subjects.
  2. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

Regulations: Good Clinical Practice and Clinical Trials, Comprehensive list of regulations governing human subject protection and the conduct of clinical trials. Guidance for Institutional Review Boards and Clinical Investigators, A series of Information Sheets providing the Agency’s current guidance on the protection of people who are subjects of research. Topics include Institutional Review Boards and Sponsor-Investigator-IRB interrelationships, FDA clinical investigator inspections and sanctions, clinical trials protocols, informed consent, and documents necessary for the conduct of clinical trials. Information for Health Professionals, Additional links to information on subject protection from FDA and other government agencies. Clinical Safety Data Management (PDF – 49KB), Provides the definitions and terminology associated with clinical safety experience and the standards for expedited reporting of adverse drug reactions that occur during clinical trials. FDA Compliance Program 7348.809 – BIMO for Institutional Review Boards (PDF – 1050MB). FDA Compliance Program 7348.811 – Bioresearch Monitoring: Clinical Investigators.

Institutional Review Board Questions: Contact the Office of Good Clinical Practice, 301-796-8340, or [email protected]

What is the purpose of the IRB?

Purpose of IRBs – Institutional Review Boards, or IRBs, review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants. Some people may also call IRBs Independent Review Boards or refer to them as Ethics Review Committees.

What is the difference between IRB and IEC?

What is the difference between an IRB and IEC? – Clinical trials conducted in the European Union are held accountable by Independent Ethics Committees (IECs). In the United States, Institutional Review Boards (IRBs) have oversight and must abide by the United States Food and Drug Administration (FDA) regulations.

Countries other than those in the European Union and the United States have individual committees and regulations. There are two types of IRBs and I ECs, local and central. Local comm ittees support individual research institutions and are responsible for reviewing only their clinical trials. Cen tral boards oversee the review of clin ical studies for many different organizations.

More specific guidelines on IRB and IEC responsibilities, composition, functions, and operations are listed in this addendum,

What is the independence of the IRB?

Updated June 23, 2021 The University strives to ensure a culture of compliance with respect to the protection of human participants involved in research. Despite the best efforts of members of the research community, there may be instances where 1) an area of concern is identified related to the conduct of a study, or 2) an individual believes she/he/they is being subjected to undue influence.

The IRB functions independently of, but in coordination with, other institutional regulatory committees. Approval by other institutional bodies cannot substitute for IRB approval. IRB disapprovals may not be superseded by other institutional authorities although studies which receive IRB approval may be deemed inappropriate for conduct at the University by other institutional authorities. The IRB may suspend or terminate approval to conduct the research if it is not being conducted in accordance with IRB’s requirements or University policies or that may cause unexpected harm to participants.

What is the relationship between IRB and institution?

An IRB is a committee — operating under federal regulations, state laws and institutional policy — that reviews research involving human subjects to ensure the ethical and equitable treatment of those subjects.

Reviews all human subject research at UCSF and affiliate sites Has the authority to approve, require changes in or disapprove research involving human subjects Includes representatives from the institutions whose research is reviewed. Members — such as physicians, nurses, pharmacists, social scientists, and at least one non-affiliated member and one non-scientist — are qualified to review the range of research at the institutions. The Senior Associate Vice Chancellor – Research appoints IRB chairs and members, Has final authority to disapprove human-subject research at the institutions. No institutional official may overrule IRB disapproval, but institutions may choose not to support or permit research that the IRB has approved. Operates in compliance with relevant federal regulations, state laws and institutional policies and with a signed agreement between the institutions and the Department of Health and Human Services, called a Federalwide Assurance (FWA) May be audited by the Food and Drug Administration, the Department of Health and Human Service’s Office for Human Research Protections and Office of Civil Rights, cooperative research groups, and UCSF Internal Audit, among others Serves as the Privacy Board for research at UCSF

It is the duty of the IRB to review and make decisions on all protocols for research involving human subjects. Its primary responsibility is the protection of subjects from undue risk and from deprivation of personal rights and dignity. This protection is best assured by consideration of three principles which are the touchstones of ethical research:

That voluntary participation by the subjects, indicated by free and informed consent, is assured That an appropriate balance exists between potential benefits of the research to the subject or to society and the risks assumed by the subject That there be fair procedures and outcomes in the selection of research subjects

These principles are summarized as respect for persons, beneficence, and justice in ” The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research ” (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 1979).

  1. At times, these issues are quite clear; other times, they are extremely difficult to evaluate.
  2. Researchers themselves should begin the process by examining their own projects in light of these principles as they prepare to seek IRB approval.
  3. The IRB then brings its collective experience in reviewing each study, always conscious of its primary responsibility to protect the rights of human subjects against exploitation, but within the context of the need for continued scientific and human progress.

Respect for Persons : The Voluntary Participation of Experimental Subjects One of the most important elements in any research involving human subjects is assurance of free and informed consent. Any person who is to be a subject of research, whether designed for his/her own direct benefit or for the advancement of scientific knowledge in general, must understand as completely as possible what is to be done and what the potential risks and benefits are.

  1. The person must give his/her consent freely, without pressure or inappropriate inducement.
  2. The IRB attempts to ensure free and informed consent of subjects through careful review of the recruitment and consent process, and of the consent form or information sheet to be used with subjects.
  3. The informed consent concept is extended to those studies in which subjects are not able to give personal consent for themselves.

Here the consent document is addressed to those who have been designated responsible for the subject’s well-being (e.g., parents for children). The Committee’s concern is to verify that the consent process and document are likely to assist these persons to make an informed decision which is in the best interests of the subject.

  1. The capacity for truly informed and voluntary participation in research varies widely among study populations.
  2. At one extreme there may be ample understanding and manifest freedom from coercion; at the other, total absence of capacity for personal consent.
  3. In between, there are many degrees of understanding and freedom that affect the consent of potential subjects.

The IRB must exercise special care when considering subjects whose ability to give free and informed consent may be compromised in any way. Beneficence: The Risk-Benefit Ratio The IRB is charged with deciding, for any proposed activity which falls under its jurisdiction, whether: “The risks to the subject are so outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept (those) risks ” ( Federal Register, May 30, 1974).

  1. The assessment of the risk/benefit relation is a complex task.
  2. There are risks of injury or discomfort to the individual that can be physical, psychological and/or social.
  3. There can be potential benefits to the individual, to a group to which the individual belongs, and/or to society.
  4. In reviewing applications, the Committee must carefully assess the types and degrees of both risks and benefits for a given subject population, as well as the investigator’s communication of these risks and benefits in the consent process and form.
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While the IRB is not charged with reviewing scientific design per se, it must sometimes do so in order to assess risk/benefit ratio. If a study design does not seem adequate to attain the stated aim of the investigation, then no benefit can be anticipated from conducting the study, and there is no justification for placing any subject at risk, however minimal.

Thus, the design of the study must be sound, and the nature and likelihood of all risks and benefits must be made clear in any application to the Committee. Justice : The Fair Selection of Research Subjects Both the risks and the potential benefits of research should be spread fairly among potential individual subjects and subject groups.

Study design and selection of subjects should avoid bias for or against particular social, racial, sexual, or ethnic groups. Sharing Research Risks : The guiding principle in the ethical selection of subject groups is that any risks of the research should fall upon the groups who might benefit from the research.

If the results of a risky protocol might benefit the general population, it would be unethical to focus subject recruitment on vulnerable or disadvantaged groups (institutionalized people or prisoners; patients at free clinics primarily patronized by people unable to afford other care) simply because they are easily accessible or can be persuaded to participate.

Groups already burdened by other factors should not also be burdened by an undue share of research risks. Rather, attempts should be made to include a fair sampling of the populations who might benefit from a study. When research involves persons whose autonomy is compromised, it is expected that the research bear some direct relationship to the conditions or circumstances of the subject population.

In addition, groups fully able to consider research risks and informed consent should be asked to face research risks before more vulnerable populations. Investigational drugs usually are tested in adults before they are tested in children. Certain investigational drugs and procedures may be tested in healthy volunteers before being tested in patients.

Sharing Research Benefits : In recent years increasing attention has been paid to the rights of various groups to be included in research. As individuals and through advocacy groups, many patients have come to insist on having access to experimental treatments as these experimental treatments may potentially provide the best medical care available.

In addition, researchers, ethicists, and public officials have recognized that because many clinical trials focused primarily on white male middle-class subject groups, the results of some trials were of questionable value for members of other social, racial, sexual, and ethnic groups. As a result, both the Food and Drug Administration and the National Institutes of Health now require that study design include as broad a range of subjects as feasible and ask that data be analyzed to uncover responses that differ between groups.

Where women of child-bearing potential and pregnant or nursing women previously were routinely excluded from new drug trials, it is now required that whenever possible these women be asked to make their own choices after being fully informed of the risks of the research.

While in the past participation in research was viewed as a burden, it is now often seen as a right. Many in society now believe that only by participating in research can an individual or a group of subjects expect to experience the benefits of the advances being made in the biomedical and behavioral fields of research.

This is a major shift in public perception of medical research. The IRB reviews research projects that involves human subjects performed by UCSF faculty, staff or students or researchers at UCSF-affiliated institutions, as described on the Research Requiring IRB Review page,

This page also defines criteria for when an activity is research involving human participants. The vast majority of the human research projects at UCSF are related to the health sciences, but the IRB reviews a broad range of research within that area. The human research participants in the studies include a wide range of individuals from all walks of life and from all over the world.

The HRPP attempts to ensure that special protections are provided for participants who are vulnerable for any reason or economically disadvantaged. Since 1966, the United States Department of Health and Human Services (DHHS), formerly called the Department of Health, Education and Welfare (DHEW), has required prior review and approval of all research using human subjects that is funded by federal agencies.

In 1970, the President of the University of California required that U.S. Public Health Service Regulations apply to “all investigations involving human subjects for which the University is responsible.” This policy was re-stated in 1981. DHEW issued its “Institutional Guide to DHEW Policy on Protection of Human Subjects” in December of 1971.

Subsequently, the University of California made the DHEW policy applicable to all human subject activities conducted by or under the direction of University employees, regardless of the source of funding or even when no funds are involved. DHEW guidelines were revised and made regulation in 1974.

Between 1974 and 1978, the National Commission on Protection of Human Subjects of Biomedical and Behavioral Research met and issued a series of reports and recommendations resulting in revised regulations issued by DHHS in January of 1981. The United States Food and Drug Administration (FDA) was simultaneously developing its own regulations, which were also issued in January of 1981 and have since been revised, most recently in October 1996.

DHHS issued revised regulations in March of 1983 and again in June of 1991. These regulations, which provided standards for review of human research activities by institutional review boards now apply to all activities involving human subjects within the University.

  1. The IRB was first created in 1966 and then restructured in 1971, both times with one panel.
  2. The second panel was created in 1997, the third in 2002, the fourth in 2005, and the fifth in 2020 following the integration of UCSF Benioff Children’s Hospital Oakland.
  3. The campus holds an approved Federalwide Assurance (FWA) from DHHS.

This is a written agreement in which UCSF describes the jurisdiction, composition, and methods of procedure by which the IRB will function, and the in the DHHS approves it. At the start of 2015, there were 5700 IRB-approved studies, up from 3500 studies in 2003.

The federal government supports 38% of the total number of human research studies at UCSF and provides 78% of the total funding for UCSF’s human research. However, industry-sponsored studies are increasing both in numbers and the amount of money awarded. There are about four biomedical studies to every one behavioral study reviewed.

It is the responsibility of the IRB to safeguard the rights and welfare of human subjects. To this end, the Committee is obligated and authorized to systematically evaluate each research study to ensure the protection of participants, including but not limited to the following:

Identify and analyze potential sources of risk and measures to minimize risk, including physical, psychological, social, legal or economic Determine that the risks to participants are reasonable in relation to potential benefits to participants and to society Review plans for data and safety monitoring in research protocols and, when applicable, determine that the plan provides adequate protection for the participants Determine risks for vulnerable populations as defined in federal regulations and determine the specific risk categories in protocols involving children and prisoners Establish and follow written procedures for suspending or terminating previously approved research if warranted by findings in the continuing review or monitoring process Evaluate the equitable selection of participants Review and permit when appropriate proposed participant recruitment methods, advertising materials, and participant payment arrangements Evaluate the protection of privacy interests of research participants and confidentiality of data in proposed research Evaluate compliance with policies and procedures for seeking informed consent from participants or their legally authorized representatives, and assent from participants when appropriate Require that prospective participants whose decision-making capacity is in question be appropriately protected Review the consent process and the consent documents, focusing on measures to improve participant understanding and voluntary decision making Require that the investigator has and follows a procedure for properly documenting informed consent Review and approve the waiver or alteration of the consent process and the waive of consent documentation when appropriate Review protocols that request exceptions to the informed consent requirements for emergency situations and approve as appropriate Have procedures for observation of the informed consent process Have procedures for the review and oversight of research conducted at multiple sites Maintain documentation of its activities Make the applications, forms, guidelines and policies necessary for the proper conduct of human research publicly available to the research community on the HRPP website Serve as the IRB of record for UCSF and affiliate institutions

Is the IRB International?

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  • IRB Guidelines on International Research

International Research: Information on Conducting Research Outside of the United States Research conducted by Fordham University faculty, staff or students in foreign countries poses unique and complex ethical challenges. Each country has different cultures and values, and it is crucial to understand the local context. As a result, the IRB expects you to acknowledge and understand the following:

  • You must obtain IRB approval before your study can begin. Whether you are a faculty member, staff or student, your research study must be approved by the IRB before it can begin. To reduce confusion, make sure you have the IRB’s approval before you leave the country. We suggest you apply to the IRB leaving adequate time for reviews before you leave.
  • Demonstrate cultural understanding and sensitivity. Your IRB protocol should describe any anticipated cultural sensitivities of conducting your research and how you intent to overcome those barriers. The researcher should be familiar with local customs, culture and religious norms in the country where the study will be conducted. Is the typical process of signing an informed consent document culturally acceptable for your study? How should recruitment be done? Are there other cultural barriers you might encounter once you arrive? The IRB will consider alternative consent form formats or methods if culturally appropriate.
  • Understand the research ethics guidelines of the host country. Investigators will be required to obtain IRB approval for research done internationally from the Fordham IRB and also from the local IRB/Ethics Committee within the country in which they will be doing their research. This approval must be on file with the IRB prior to IRB approval being granted. The IRB strongly recommends you clearly understand the host country’s requirements for reviewing and approving human subject research. Some countries have clear ethical guidelines that must be met for conducting domestic and/or international research. Other countries will not have a formal process but might rely on other neighboring countries to assist with the review. Where there is no equivalent board or group, researchers must rely on local experts or community leaders to provide approval. If the researcher has difficulty determining the existence of an IRB/Ethics Committee in the foreign country, they should contact the IRB.
    • The Office of Human Research Protections (OHRP) publishes the International Compilation of Human Research Standards, a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and several international organizations. Researchers should check this document to determine the countries applicable laws, regulations and guidelines on Human Subjects Researcher.
    • The Office of Human Research Protection (OHRP) has issued a Listing of 27 Social-Behavioral Research Standards, This includes laws, guidelines, and regulations applicable to social-behavioral research around the world.
    • Know the data laws. While not specifically under the IRB’s domain, you should know that there are some restrictions on bringing identifiable data into/out of some countries. The EU, for example, has laws surrounding what kind of identifiable information can be taken out of Europe and brought to the US (this applies to electronic data that will be housed on a US server as well). Data export laws may also affect your research in countries with which the US has embargoes or trade restrictions, such as Iran.
  • Please contact the IRB while abroad if you encounter any problems or need to change your IRB-approved protocol. If you find that upon arrival in the host country, some aspects of your research study must be modified for whatever reason, please notify the IRB office immediately, The IRB will do its best to quickly respond to your notification with further instructions and guidance. Please wait to hear back from the IRB before making any changes to your protocol!
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What information should be in your IRB application? In your IRB submission, it is important that you tell us what you know about the country where the study is being conducted. The IRB relies on the information you provide to help assess whether the rights protections are in place for subjects.

  • Your IRB protocol should describe relevant local context information, any anticipated cultural sensitivities of conducting your research and how you intent to overcome those barriers. This should include, but not limited to the following:
    1. Cities, regions countries where research will be conducted
    2. Scientific/ethical justification for conducting the research in an international setting
    3. Economic status of the country/community
    4. Current events or socio-political environment in the country that may impact research conduct or alter the risks or benefits to subjects
    5. Societal and cultural beliefs in the country that may impact research conduct or alter the risks or benefits to subjects
    6. The role of women and children in the society, including their autonomy and legal capacity to make decisions
    7. Literacy rate of the potential subject population
    8. Languages and dialects of the potential subject population
    9. Involvement of organizations, community leaders, or experts in engaging the subject population or conducting the research
    10. Description of the research team’s knowledge of or experience in the host country
    11. Relevance of the research to the area’s health, economic, educational, or other needs
    12. Distribution of risks and current and future benefits
    13. Detail any proposed remuneration (payment, gifts, incentives, etc.) for subjects including:
      • Specific description of the remuneration (payment, gifts, incentives, etc.)
      • Value both in US and local currency
      • Local household income information (e.g. how much an average household earns in a month or a year in US and local currency)
      • When remuneration will be given during the study (the payment schedule)
      • To whom remuneration will be given
      • Whether the remuneration could pose undue influence on the subject’s decision to participate.
  • Approval letter from the local IRB/Ethics Committee within the country where research will be conducted. equivalent board or group, researchers should provide an explanation of such and should consult with local experts or community leaders to provide an approval letter that the research as proposed meets local standards.
  • The consent form should be submitted in both the local language of the host country and in English. Please clearly label each form for the IRB. The application should also indicate who conducted the translation of the forms and provide a letter certifying the translations are correct.
  • Local contact information for participants to contact about research related questions.
  • Recruitment materials to be used in both the local language of the host country and in English.
  • Describe how you will keep your data secure at all stages: while you are collecting it in the host country, while you are traveling back to the US and once you arrive here.

How many IRB members are required?

§ 56.107 IRB membership. – ( a ) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

In addition to possessing the professional competence necessary to review the specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.

* * * The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with those subjects.

B ) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the instituton’s consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

( c ) Each IRB shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas. ( d ) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

E ) No IRB may have a member participate in the IRB’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. ( f ) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of complex issues which require expertise beyond or in addition to that available on the IRB.

These individuals may not vote with the IRB.

Do all studies need IRB approval?

Research Requiring IRB Review – The IRB must review and approve all research involving live humans before any such research activities may begin. When Was The Institutional Review Board Established Research involving human subjects must receive IRB approval in accordance with federal regulations set forth by the U.S. Department of Health and Human Services (HHS) (known as the “Common Rule”) and the U.S. Food and Drug Administration (FDA). A project may be subject to one or both sets of regulations depending on whether the project meets the definition for Human Subjects Research (HHS) and/or Clinical Investigation (FDA).

  • HHS Definition of Research (Common Rule)
  • “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
  • In general activities that contribute to generalizable knowledge are those that:
  • attempt to make comparisons or draw conclusions based on the data;
  • seek underlying principles that have predictive value and can be applied to other circumstances;
  • identify general explanations or themes that a reader can extrapolate to another situation.

Although publication is often viewed as evidence of research status, it is not the only criterion. In fact, “systematic investigations” often result in published information, yet they do not qualify as research because they were not designed to contribute to generalizable knowledge.

  1. HHS Definition of a Human Subject (Common Rule)
  2. Human subject – A living individual about whom an investigator (whether professional or student) conducting research:
  3. (1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
  4. or
  5. (2) Obtains, uses, studies, analyzes, or generates identifiable private information or biospecimens.

Intervention includes both physical procedures by which data are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g. a medical record). Identifiable information means that the identity of the subject is, or may be readily ascertained (directly or indirectly) by the investigator (or others) or associated with the information.

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FDA Definition of a Clinical Investigation “Any experiment that involves a test article and one or more human subjects that is either subject to requirements for prior submission to the Food and Drug Administration under section 505(i), or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted to, or held for inspection by the Food and Drug Administration as part of an application for a research or marketing permit.” The term does not include experiments that are subject to the provision of 21 CFR 58, regarding nonclinical laboratory studies. Under FDA regulations, the terms “research” and “clinical investigation” are synonymous. A test article means any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug and Cosmetic Act, FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements), FDA Definition of a Human Subject FDA Human subject – an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.

Is IRB Approval Required?

What is the history of the Institutional Review Board?

Administration – Today, four IRBs review biomedical and behavioral research involving human subjects at Fred Hutch. The IRBs review all research submitted by Fred Hutch and the Fred Hutch/University of Washington Cancer Consortium. The Fred Hutch IRBs review any research project involving research participants, regardless of its funding source.

Fred Hutch IRBs review and approve research in accordance with U.S. Department of Health and Human Services regulations at 45 CFR 46, In addition, for studies involving products regulated by the U.S. Food and Drug Administration, the Fred Hutch IRBs comply with the requirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312 and 21 CFR 812.

The chairs of each IRB are:

Committee A: Brenda Sandmaier, M.D. Committee B: David Maloney, M.D., Ph.D Committee C: Roland Walter, M.D., Ph.D., M.S. Committee D: Stacey Cohen, M.D.

The Institutional Review Office, or IRO, administers all activities requiring IRB review. The IRO reports directly to the Office of the Director of Fred Hutch. Fred Hutch IRB meetings are held four times per month. View the schedule of meetings and submission deadlines.

What are the benefits of IRB?

Ethical Considerations – When making this determination in research with adult populations, t he IRB weigh s the risks to participants against the anticipated benefits (either direct or indir ect) of the research, When vulnerable subjects take part, the regulations place limits on the extent of risk permitted,

  • Identify and compare the risks associated with the research from the risks of therapies or alternatives to participation in research,
  • Determine that the risks will be minimized.
  • Identify the anticipated benefits to be derived from the research.
  • Determine that the risks are reasonable in relation to be benefits to subjects, if any, and the importance of the knowledge to be gained,
  • Verify research participants will be provided with an accurate and fair description (during the consent process ) of the risks an d/or the anticipated benefits,

Who is the biggest IRB?

Expect the Very Best. – When you work with us, you get the elevated IRB experience you need from a partner you can trust. With more than 50 years of industry experience and a global reach with the world’s largest IRB and IBC network, WCG IRB is proud to serve its clients with the highest ethical standards and world class service. When Was The Institutional Review Board Established

Who needs an IRB?

Does my Research Need IRB Review? Office of Research Integrity, IRB/RCR Specialist, 401.874.4328, Associate Director, 401.874.4813, Associate Vice President for Research Administration, 401.874.2636 or, 401.874.4328 contains FORMS, Policies, Templates, Guidance, Tools, Instruction and Training Material, and other resources to support your research efforts by topic area.

If your activity doesn’t fit one of the definitions of research (below), you do not need to obtain IRB approval or a determination of exempt status. The specific definition (if any) that applies to your activity determines which regulations and requirements govern your research.

The Regulations Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities. The IRB cannot provide approval or determinations for research that has already been concluded. IRB review and approval is required for projects that:

Meet the definition of research Involve human subjects and Include any interaction or intervention with human subjects or involve access to identifiable private information

What is Research? When Was The Institutional Review Board Established Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. A Systematic Investigation follows a predetermined plan for looking at a particular issue, testing a hypothesis or research question, or developing a new theory that may include:

Collection of quantitative or qualitative data Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups Collection of data using experimental designs such as clinical trials Observation of individual or group behavior

Contribute to Generalizable Knowledge means that the purpose or intent of the project is to test or to develop scientific theories or hypotheses, or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being studied. This may include one or more of the following:

Presentation of the data at meetings, conferences, seminars, poster presentations, etc. The knowledge contributes to an already established body of knowledge Other investigators, scholars, and practitioners may benefit from this knowledge Publications including journals, papers, dissertations, and master’s theses

If the project does not meet the definition of research (i.e. is not a systematic investigation or does not contribute to generalizable knowledge), as described above, then the project does not require IRB review and an IRB application is not required.

My Project is Considered Research, Now What? If the project meets the definitions of research (i.e. is a systematic investigation or does contribute to generalizable knowledge), as described above, the next set of questions apply. Are Human Subjects Involved? A Human Subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.

If the project does not meet the definition of research or the project does not include human subjects, as described above, then the project does not require IRB review. When Was The Institutional Review Board Established My Project Includes Human Subjects, Now What? If the project does include a human subjects aspect, you need to determine if there is any interaction or intervention with subjects or if there is any access to identifiable information.

Interaction– Any communication or interpersonal contact between the investigator(s) and the subjects. This includes in-person, mail, telephone, etc. Online surveys (even if anonymous) involve interaction. Intervention– Physical procedures or manipulations of the subject or his/her environment (e.g. taking blood samples, exercise studies, use of devices, cognitive tasks, etc.)

Access to Identifiable Private Information Private Information– Information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place (e.g. person’s home, exam room, public restroom, etc.) OR has been provided for specific purposes with a reasonable expectation that it will not be made public (e.g.

medical records, student records, employee file, etc.) Identifiable Information– The identity of the individual is or may be readily ascertained by the investigator or others either directly or indirectly through the use of codes or a combination of data points. If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review.

If even one of the above categories are met (intervention, intervention, access to identifiable private information), an IRB application is required. Example of Studies that Generally Require IRB Review

Pilot studies that involve human subjects Master’s theses Dissertations Use of identifiable information from medical records, student records, employment records, or other private sources, Research studies that collect data about human subjects through interaction or intervention with subjects, such as surveys (paper, online, telephone, etc.), interviews, focus groups, cognitive testing, etc. Research studies that include subjects to examine devices, products, food, drugs, supplements, etc.

Examples of Studies that Generally Do Not Require IRB Review

Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc. Activities designed solely for quality improvement or evaluation of a program, course, etc. Oral histories or biographies (unless data will also be used to contribute to generalizable knowledge) Training activities unless the training activity is conducted for research purposes Single case studies

: Does my Research Need IRB Review?

How long is IRB approval?

IRB Review Timeline – Office of Research Support and Compliance Once a PI or a PI Proxy has submitted an IRB application in UTRMS-IRB, the study status moves from Pre-Submission to Pre-Review. IRB review begins at Pre-Review state following the timeline below.

  • Exempt studies, posing minimal risk to human subjects, take approximately 2-3 weeks to be processed from the date received by RSC.
  • Expedited studies take approximately 3-4 weeks to be processed from the date received by RSC.
  • These processing timelines relate to when RSC staff provide feedback to the PIs regarding any actions that may be needed in preparing the study for IRB review and approval.

An IRB approval timeline cannot be provided as it will vary from one submission to another. It is important to remember that both exempt and expedited studies are reviewed “in house,” and thus, the full board does not review them. Therefore, the full board meeting and agenda dates and deadlines are not applicable to exempt and expedited studies. When Was The Institutional Review Board Established : IRB Review Timeline – Office of Research Support and Compliance

What is IRB called in Europe?

Institutional Review Board (IRB)/Independent Ethics Committee (IEC) ⋆ Vial Institutional review boards (IRB), also known as independent ethics committees (IEC) in the European Union, are formally designated independent bodies that safeguard the rights, safety, and well-being of all human subjects involved in a trial.

These bodies review and monitor clinical trial documents (protocol, informed consent documents, investigator brochures, and advertising material) in advance and by periodic review in accordance with written operating procedures. The IRB has the authority to approve, require modifications prior to giving a favorable opinion, disapprove, or terminate/suspend any prior approval of the research.

Records must be kept for three years after the completion of the trial. IRBs are composed of medical and nonmedical members that have no conflicting interest with the clinical trial. Regulations require IRBs to have a diverse membership, which can be in terms of race, gender, cultural background, and community members.

Is there IRB in Europe?

Answering international research questions since 1986 “We recently commissioned an in-depth study with IRB Europe to support our distribution strategy in Europe. This successful B2B study, which was conducted face to face in 9 markets, confirmed objectively some things we had suspected, and added keen insights in certain important areas”.

What are our customers’ needs in terms of products or services, and are we meeting them? Why do some potential customers choose to work with our competitors rather than us? How do our prices compare with those of our competitors? How good is our relationship with our distributors and dealers? What are the major trends in the market, and the key opportunities for us?

Our research is tailor-made to the client’s needs. We use the full range of market research techniques, including multi-lingual phone surveys, face-to-face interviews and focus groups, mystery shopping, on-line surveys and internet research. : Answering international research questions since 1986

What is IRB vs IBC?

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring additional oversight by an institutional biosafety committee (IBC). In the clinical research community, we’re already familiar with IRBs, which also reviews risks.

So what’s the difference between an IBC and an IRB? – While both committees focus on risk, they have contrasting responsibilities. IRBs are tasked with protecting the rights and welfare of research subjects. IBCs, however, seek to protect study personnel, the community and the environment from exposure to engineered genetic material and other biohazardous agents.

An IBC may also advise the IRB in assessing potential risks to the study subjects. While one IRB can oversee research protections for multiple sites, IBCs are locally based at the research site, include the involvement of community members and can only oversee research at that location.

  • For the sake of efficiency, local IBC meetings can be centrally coordinated and synchronized, but each IBC remains responsible for local review.
  • Because of the risks involved, gene therapy research requires additional safety measures to ensure that research subjects and study staff as well as the community and the environment surrounding the research site are not harmed by the modified genetic material or the infectious agents that may be utilized to deliver them.

These safety measures go beyond the human subject protection requirements that IRBs enforce and always require a site inspection as part of the approval process. The IBC’s review is intended to ensure a thorough risk assessment is performed regarding the risks associated with the genetically modified materials.

  • The IBC also reviews to confirm that a comprehensive risk mitigation plan is in place prior to starting the research.
  • IBCs help researchers apply the necessary safety measures to ensure gene therapy research is conducted safely and responsibly.
  • It’s possible that an IRB’s membership might be similar to that of an IBC, but remember that each committee is composed to conduct its review for different purposes.

IBCs include members who possess expertise in genetic engineering, biological safety, infectious diseases and environmental protection. Each IBC is required to have at least two community members who are unaffiliated with the institution or research site and who represent the interests of the community and the local environment.

IRB IBC
Required when: Research involves human subjects Research involves gene therapy or genetic engineering
Responsibility (oversight for:) Protecting human subjects participating in research Protecting human subjects, study personnel, the community and the environment when conducting gene therapy or genetic engineering research
Composition Minimum 5 members with varying backgrounds, including:

At least 1 scientific member At least 1 non-scientific member At least 1 member not affiliated with the institution/IRB

Minimum 5 members that collectively have the expertise to assess risks associated with recombinant DNA research, including:

At least 2 members from local community who are not affiliated with the institution/site

Central vs local

Centralized review of multiple sites by a single IRB permitted Local review by site-specific IRB

IBC must be site-specific with local community members Central administration of IBC permitted

There are many more distinctions we could explore, but hopefully this article has helped you understand the main differences between IRBs and IBCs. In a nutshell: IRBs are concerned with risks to human research subjects, and IBCs are concerned with risks to anyone who might come in contact with a study’s genetically modified material.

Who audits the IRB?

FDA conducts IRB inspections to determine if IRBs are operating in compliance with current FDA regulations and statutory requirements and if the IRBs are following their own written procedures.

Who created the Belmont Report?

BELMONT REPORT – Ethical Principles and Guidelines for the Protection of Human Subjects of Research The Belmont Report was written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission, created as a result of the National Research Act of 1974, was charged with identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and developing guidelines to assure that such research is conducted in accordance with those principles.

Who regulates the Institutional Review Board IRB in the United States?

An Institutional Review Board (IRB) is an administrative committee designated to provide ethical and regulatory oversight of research that involves human subjects. IRBs exist to protect the rights, safety, and welfare of human subjects involved in research projects, consistent with ethical principles and federal, state and local regulations.

  • For human subject research conducted internationally, additional local regulations and international standards apply and are overseen by ethics committees in respective countries.
  • IRBs are enacted under federal regulation, specifically 45 CFR 46, and are regulated by the Office for Human Research Protections (OHRP) within the U.S.

Department of Health & Human Services (HHS), There are additional requirements for IRBs overseeing clinical trials of drugs involved in new drug applications from the Food and Drug Administration ( 21 CFR 56.111 ) and for studies supported by the Department of Defense,

What is the independence of the IRB?

Updated June 23, 2021 The University strives to ensure a culture of compliance with respect to the protection of human participants involved in research. Despite the best efforts of members of the research community, there may be instances where 1) an area of concern is identified related to the conduct of a study, or 2) an individual believes she/he/they is being subjected to undue influence.

The IRB functions independently of, but in coordination with, other institutional regulatory committees. Approval by other institutional bodies cannot substitute for IRB approval. IRB disapprovals may not be superseded by other institutional authorities although studies which receive IRB approval may be deemed inappropriate for conduct at the University by other institutional authorities. The IRB may suspend or terminate approval to conduct the research if it is not being conducted in accordance with IRB’s requirements or University policies or that may cause unexpected harm to participants.